The present invention is directed toward hyperbaric apparatus for applying oxygen to leg wounds and, more particularly, to a disposable, inflatable hyperbaric chamber and to a method of applying and utilizing the same.
As is well known in the art, hyperbaric chambers are devices which create sealed and pressurized environments for the treatment of lesions and wounds on a patient's body. It has been well established that hyperbaric oxygen is an effective treatment for wounds as the same induces the growth of new blood vessels or neovascularization necessary for stimulating the growth of new tissue in order to close defects in wounds.
Devices have been proposed in the past for treating leg ulcers or other leg wounds utilizing hyperbaric oxygen. These prior devices are comprised essentially of a rigid chamber having an opening at one end through which the leg can be inserted. Such prior hyperbaric chambers are described, for example, in U.S. Pat. No. 4,003,371 to Fischer and U.S. Pat. Nos. 4,296,743 and 4,432,353 to Lasley.
The prior art hyperbaric oxygen chambers such as those proposed by Fischer and Lasley are relatively expensive and are difficult to sterilize, thereby creating cross-infection between patients using the same chambers for therapy. Furthermore, these prior art chambers were relatively large, rigid and immovable. Accordingly, during treatment, the patient was required to lie in a prone position at all times.
In an article published by Heng et al. in Arch Dermatol in 1984, a technique for administering hyperbaric oxygen is disclosed which utilizes a disposable polyethylene bag. This technique has the advantage of being substantially simpler than more complex hyperbaric oxygen chambers and is less likely to cause cross-infection. The technique previously proposed by Heng et al., however, is still believed to be deficient in the manner in which the bag is closed and secured to the patient and in the inability to allow the patient to be ambulatory while receiving treatment.
A similar problem exists with the apparatus shown in U.S. Pat. No. 5,029,579 to Trammell. Trammell discloses an arrangement which utilizes a flexible disposable bag but which must be continuously connected to a pulsating oxygen source. As a result, the patient can not be ambulatory. Furthermore, in both the Heng et al. and Trammell arrangements, there is no easy and convenient way of securing the flexible bag to the patient's leg.